[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover fasting and fed bioequivalence study of faropenem sodium tablets in healthy subjects

本试验旨在研究健康受试者单次空腹和餐后口服海南海灵化学制药有限公司研制、生产的法罗培南钠片（200 mg）的药代动力学特征；以Maruho Co., Ltd持证、生产的法罗培南钠片（Farom®，200 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

This study aimed to investigate the pharmacokinetic characteristics of faropenem sodium tablets (200 mg) developed and produced by Hainan Hailing Chemical Pharmaceutical Co., Ltd. after single fasting and postprandial oral administration in healthy subjects; Faropenem sodium tablets (Farom®, 200 mg) licensed and produced by Maruho Co., Ltd were used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.

Start Date02 Sep 2024

Sponsor / Collaborator

Hainan Hailing Chemipharma Corp. Ltd.

CTR20242482 / CompletedNot Applicable

盐酸米诺环素胶囊（50 mg）在健康受试者中的空腹和餐后生物等效性试验

[Translation] Bioequivalence study of minocycline hydrochloride capsules (50 mg) in healthy subjects after fasting and feeding

主要目的：在健康受试者中，评价Pfizer Japan Inc.持证的参比制剂盐酸米诺环素胶囊（MINOMYCIN，50 mg （按C23H27N3O7计））与浙江华海制药科技有限公司生产的受试制剂盐酸米诺环素胶囊（50 mg（按C23H27N3O7计））在空腹和餐后条件下的生物等效性。次要目的：观察受试制剂盐酸米诺环素胶囊与参比制剂盐酸米诺环素胶囊（MINOMYCIN）在健康受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the reference preparation minocycline hydrochloride capsules (MINOMYCIN, 50 mg (calculated as C23H27N3O7)) certified by Pfizer Japan Inc. and the test preparation minocycline hydrochloride capsules (50 mg (calculated as C23H27N3O7)) produced by Zhejiang Huahai Pharmaceutical Technology Co., Ltd. under fasting and fed conditions in healthy subjects. Secondary objective: To observe the safety of the test preparation minocycline hydrochloride capsules and the reference preparation minocycline hydrochloride capsules (MINOMYCIN) in healthy subjects.

Start Date02 Aug 2024

Sponsor / Collaborator

Zhejiang Huahai Pharmaceutical Technology Co., Ltd.

CTR20241134 / CompletedNot Applicable

盐酸米诺环素胶囊在健康受试者中单中心、随机、开放、单剂量、两制剂、两周期、两序列交叉设计在空腹给药和餐后给药两种状态下人体生物等效性研究

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover design of minocycline hydrochloride capsules in healthy subjects under fasting and fed conditions

本试验旨在研究单次空腹和餐后口服安徽省先锋制药有限公司研制、生产的盐酸米诺环素胶囊（100 mg）的药代动力学特征；以Pfizer Japan Inc.持证、ファイザ一株式会社生产的盐酸米诺环素胶囊（MINOMYCIN®，100 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

This study aimed to investigate the pharmacokinetic characteristics of minocycline hydrochloride capsules (100 mg) developed and produced by Anhui Pioneer Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal; minocycline hydrochloride capsules (MINOMYCIN®, 100 mg) licensed by Pfizer Japan Inc. and produced by ファイザ一 Co., Ltd. were used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.

Start Date01 May 2024

Sponsor / Collaborator

Anhui Pioneer Pharmaceutical Co. Ltd.

100 Clinical Results associated with Dacryocystitis

100 Translational Medicine associated with Dacryocystitis

0 Patents (Medical) associated with Dacryocystitis

1,724

Literatures (Medical) associated with Dacryocystitis

01 Dec 2024·American Journal of Ophthalmology Case Reports

Pediatric dacryolith masquerading as congenital nasolacrimal duct obstruction

Article

Author: Ranjan, Ashish ; Ali, Mohammad Javed ; Pokal, Upasana

PurposeTo report a rare case of a pediatric dacryolith masquerading as congenital nasolacrimal duct obstruction (CNLDO).ObservationsA two-year-old male child presented with history of intermittent epiphora and discharge since the age of six months. Clinical evaluation demonstrated raised tear meniscus height and delayed fluorescein dye disappearance test in the right eye. Lacrimal irrigation of the right eye under general anesthesia demonstrated 90 % regurgitation (subjectively) of mucoid fluid with a hard stop. Nasal endoscopy examination demonstrated a dacryolith obstructing the opening of the nasolacrimal duct (NLD) in the inferior meatus. The dacryolith was teased out of the NLD and following its removal the lacrimal irrigation was freely patent. At six-months post operative follow up, epiphora resolved and the child was asymptomatic.Conclusions and importanceWhile cases of canaliculitis is uncommon in pediatric age group, it is rare to find a NLD dacryolith in a toddler. To the best of the authors' knowledge, there are few prior reports on pediatric NLD dacryolith masquerading as CNLDO in a toddler (1-3 years).

01 Dec 2024·American Journal of Ophthalmology Case Reports

Pediatric dacryolith masquerading as congenital nasolacrimal duct obstruction

Article

Author: Ranjan, Ashish ; Ali, Mohammad Javed ; Pokal, Upasana

01 Nov 2024·Journal Français d'Ophtalmologie

Lacrimal canaliculitis as a mimicker of conjunctival tumor

Article

Author: Nakaizumi, T. ; Nakaizumi, T ; Nakajima, I ; Nakajima, I. ; Tsuji, H ; Tsuji, H.

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